Announcement PDF AGM Chairman’s address and CEO’s presentation Melbourne, Australia; 29 November 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) releases the attached Chairman’s address and the CEO’s presentation to the Annual General Meeting (AGM) of Starpharma Holdings Limited, to be held today at 2:00 pm (Melbourne time). About Starpharma Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a world leader in dendrimer technology for medical applications. As an innovative Australian biopharmaceutical company, Starpharma is focused on developing and commercialising novel therapeutic products that address significant global healthcare needs. Starpharma boasts a strong portfolio of products, partnerships, and intellectual property. Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications. Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing pharmaceuticals. Starpharma’s portfolio includes multiple clinical-stage oncology products, which utilise its Dendrimer Enhanced Product (‘DEP®’) drug delivery technology, and marketed products, including VIRALEZE™ and VivaGel® BV, which utilise SPL7013, a proprietary dendrimer with antimicrobial properties. Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to reduce drug-related toxicities through controlled and specified drug delivery. In addition to Starpharma’s internal DEP ® programs, Starpharma has multiple DEP® partnerships with international biopharmaceutical companies, including AstraZeneca (oncology), MSD (Antibody-Drug Conjugates), Chase Sun (anti-infectives), and other world-leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform, partnered DEP® programs have the potential to generate significant future milestones and royalties. Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including Europe, the UK, and Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV, is registered in more than 50 countries, including in the UK, Europe, Southeast Asia, South Africa, Australia and New Zealand. For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn. WE Communications Hannah Howlett +61 4 5084 8064 WE-AUStarPharma@weworldwide.com Starpharma Holdings Limited Dr Jackie Fairley, Chief Executive Officer Justin Cahill, CFO and Company Secretary +61 3 8532 2704 investor.relations@starpharma.com 4-6 Southampton Crescent Abbotsford Vic 3067 Disclosure This ASX Announcement was authorised for release by the Chair, Mr Rob Thomas. Forward-Looking Statements This document contains certain forward-looking statements relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, “outlook”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forwardlooking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialisation of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance, and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document nor any information made available to you is or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or future performance of any Starpharma product. Starpharma Holdings Limited Annual General Meeting 29 November 2023 Chairman’s Address to Shareholders Good afternoon, fellow shareholders. On Behalf of the Board of Directors, I am pleased to welcome you to Starpharma’s Annual General Meeting. First, I want to acknowledge the disappointing performance of our company’s share price, which has significantly impacted our shareholders. The pharmaceutical and biotechnology industry has been facing challenges globally, and the sector indices in both the US and Australia have been falling this year. Unfortunately, Starpharma has not been immune to these sector-wide pressures, and regrettably, our share price also suffered disproportionately following AstraZeneca’s news midway through this year. Fund flows associated with market conditions, changes in portfolio managers and index fund changes have also significantly impacted Starpharma’s share price. This is despite multiple positive announcements in recent months, including impressive DEP ® clinical trial results. The Company continues to seek to mitigate the impact of these by engaging with new investors, including via investor events and one-on-one meetings. Notwithstanding market challenges, it is important to remember the strong fundamentals of Starpharma’s business. These fundamentals include our innovative DEP® drug delivery platform, deep portfolio of high-value assets, multiple partnerships with global pharmaceutical companies, strong leadership, and a robust financial position. In the pharmaceutical industry, having a solid portfolio of products is crucial, and Starpharma is in a strong position from that perspective. Over the last 12 months, we have made significant progress in advancing and strengthening our portfolio, demonstrated by the recent highly positive results from the DEP® cabazitaxel, DEP® irinotecan, and DEP® radiotheranostics programs. Importantly, Starpharma has a deep portfolio with patented products for different indications and at different stages. In addition, our DEP® platform allows us to have multiple partnered programs with the potential for significant value creation in parallel with our internal products. The DEP ® platform continues to attract interest from new potential partners, including in innovative research areas, like antibody-drug conjugates (ADCs), providing Starpharma with additional commercial opportunities and optionality. Also, with a strong balance sheet and cash runway, Starpharma is well-placed to advance our product pipeline and implement our strategic plans, ensuring a strong pathway for future growth. We were delighted to recently announce the appointment of Starpharma’s next CEO and Managing Director, Ms Cheryl Maley, who will assume the role in January 2024. Cheryl is a highly qualified industry professional who brings a wealth of knowledge and expertise to Starpharma. Cheryl has over 25 years of experience in the pharmaceutical industry, including 20 years in leadership roles at global and leading organisations, including Novartis and AbbVie. Cheryl has demonstrated global leadership capability as a results-focused executive, and her commercial expertise will be an asset as we continue to progress the development of our products for patient and commercial outcomes. The Starpharma Board, management team, and I are excited to welcome Cheryl to the Company. In 2023, we completed recruitment across all three of our Phase 2 DEP® clinical trials. This is a significant milestone for the Company. We have since reported very positive clinical data from two of our Phase 2 oncology programs to date, DEP® cabazitaxel and DEP® irinotecan, with more clinical results expected in the coming months. In these clinical trials, we have successfully demonstrated the therapeutic value and clinical utility of Starpharma’s DEP® platform. The positive results reported from our trials have shown improvements in efficacy across multiple cancer types and reductions in important toxic side 1 effects. The results have also compared favourably on several levels to the conventional formulation of these drugs. Pleasingly, we have also received very encouraging feedback from medical oncologists and clinical investigators involved in the DEP® trials, who have been impressed by the data. Of particular note and interest for investigators, DEP® cabazitaxel demonstrated very positive results in patients with ovarian cancer and gastro-oesophageal cancers, for which conventional cabazitaxel is not currently indicated. Furthermore, patients and their oncologists have reported significantly improved tolerability and quality of life with DEP® irinotecan compared to their experience with conventional irinotecan. Multiple patients have expressed their preference for Starpharma’s DEP® version, having previously failed or been unable to tolerate the conventional drug. These trial results and clinical feedback further validate Starpharma’s DEP® platform and the significant benefits our DEP® technology can deliver in cancer treatment – not only in improving the effectiveness of treatments but also in improving tolerability and the patient experience. Cancer treatment can be challenging for patients, their families, and their treating physicians. Products that can avoid or alleviate dose-limiting adverse effects of clinically proven drugs while achieving impressive disease control in heavily pre-treated advanced cancer patients have significant commercial potential and can play a crucial role in improving the overall patient experience. Starpharma's dendrimer technology offers numerous advantages when it comes to drug delivery. DEP® improves efficacy and tolerability, enhances solubility and pharmacokinetics, achieves significant tumour targeting, and creates new and extended intellectual property. The broad applicability of the DEP® platform is hugely beneficial as it can provide therapeutic and commercial value across a wide range of therapeutic areas and treatment modalities, including chemotherapeutics, antibody-drug conjugates, radiotheranostics, anti-infectives, and more. Starpharma’s DEP® platform is certainly becoming increasingly recognised by partner organisations as a means to create improved drugs with specifically designed features. We already have a number of valuable partnerships with major global pharmaceutical companies. I know many investors have focused on the AstraZeneca partnered program, AZD0466, which was being trialled in two blood cancer indications. AstraZeneca enlisted Starpharma’s DEP® to reduce the toxicity of a promising oncology drug after trying several other delivery technologies. With our DEP® technology, we significantly expanded the therapeutic window of their drug by more than 20fold, enabling it to be advanced into human trials for the first time. So, while the subsequent discontinuation of the AZD0466 development is disappointing, these results do validate the ability of our DEP® technology to significantly reduce toxicity. AstraZeneca ultimately made a decision based on their internal risk-benefit analysis within the context of their haematology pipeline. Whilst this decision is not what we hoped for, the AZD0466 program with AstraZeneca did achieve several important milestones and generated significant IP that has application elsewhere. It was instrumental in raising the profile of DEP® and the growth and diversity of our business. Through extensive publications, it has led to broader recognition of the benefits afforded by DEP® in drug delivery, as well as facilitated new and expanded partnerships with other major global companies, like MSD and Genentech. Our ongoing partner programs with both MSD and Genentech have made significant progress this year and since their commencement. Both partnerships have expanded to include additional programs involving the application of DEP®. This year, we were excited to expand our partnership with MSD in the innovative area of cancer treatment, Antibody-Drug Conjugates (ADC), and saw significant progress. We anticipate further updates on these programs in 2024. In relation to VIRALEZE™ Nasal Spray, we have successfully registered the product in more than 35 countries to date and continue to market VIRALEZE™ through several e-commerce channels and other commercial partner arrangements. The Company continues to pursue additional registration and commercial opportunities elsewhere. Regarding VivaGel® BV, Starpharma’s non-antibiotic gel for treating bacterial vaginosis (BV) and preventing recurrent BV, we successfully negotiated a favourable commercial settlement 2 agreement with Mundipharma in August 2023. Under this agreement, Starpharma received a $6.6 million cash payment and regained all rights to the product, allowing Starpharma to seek new commercial partners. We are progressing several discussions with a number of potential partners for either local, regional or country rights, and we look forward to further announcements in the coming months. Starpharma focuses on developing innovative healthcare products and remains committed to its Environmental, Social and Governance pillars and corporate sustainability. We take pride in producing a comprehensive ESG Report annually, highlighting our commitments to good governance, employee well-being, supply chain responsibility, and reducing our environmental impact. I strongly encourage you to read this report and learn more about our ESG efforts and initiatives. I want to express my gratitude to the highly skilled and dedicated staff at Starpharma, who consistently demonstrate unwavering commitment to the business. Despite being a relatively small team of around 40 individuals, they have made significant progress. I also want to thank my fellow Board members for their leadership. We were delighted to welcome Dr Russell Basser to the Board as a non-executive director this year, bringing over 30 years of international medical and biopharmaceutical expertise as a corporate executive and medical oncologist. Starpharma also welcomed Mr Justin Cahill as Chief Financial Officer and Company Secretary in April 2023. As you know, upon Cheryl’s commencement in January 2024, Dr Jackie Fairley will retire as CEO and Managing Director, which means this will be Jackie’s final AGM with Starpharma. The Board and I thank Jackie for her unwavering dedication and commitment to Starpharma. Under her leadership, the Company has grown from a start-up organisation to a mature and established business with a deep portfolio, a strong reputation for excellence and multiple partnerships with leading companies. Jackie will remain available in an advisory capacity if required to assist with the transition until June 2024. I want to reiterate the Board and management team’s commitment to a smooth transition. Finally, we would like to express our sincere gratitude to all our shareholders for their patience and support during a challenging market period. Your Board and management team are committed to delivering positive returns for the Company and our shareholders. Following positive developments across our portfolio this year, 2024 presents multiple commercial opportunities for Starpharma and our portfolio of partner and internal programs. Looking ahead, the Company is focused on further unlocking the commercial potential of its products, expanding our partnerships, and creating value for our shareholders. Thank you. Rob Thomas, AO Chairman 3 ASX: SPL OTC: SPHRY Starpharma Annual General Meeting 2023 Dr Jackie Fairley, Chief Executive Officer 29 November 2023 1 Important notice and disclaimer This document is intended for investors and market participants only. This document contains certain forwardlooking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, “outlook” or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialisation of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this presentation and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document, nor any information made available to you is or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or future performance of any Starpharma product. This document is intended for people seeking information about Starpharma for investment and business purposes. This document contains information about products that may not be available, or approved, in all countries, or may be available under different trademarks, or for different indications. Nothing contained in this document should be considered a solicitation, promotion, or advertisement for any product, including those under development. Any information in this document is not intended to provide medical advice nor should be used as a substitute for the advice provided by a doctor or other healthcare provider. FLEURSTAT BVgel (VivaGel® BV) for the treatment of BV and relief of symptoms, and prevention of recurrent BV and its symptoms: ASK YOUR PHARMACIST ABOUT THIS PRODUCT. Do not use for more than 7 days unless a doctor has told you to. See your doctor if symptoms persist after 7 days or recur within 2 weeks of completing a course, or if you consider you may be at risk of a sexually transmitted infection (STI). See a doctor if you are diabetic or pregnant/breastfeeding (or plan to be). You can use Fleurstat Bvgel when you don’t have symptoms to help prevent recurrent BV and its symptoms. Recurrent BV is typically 3 or more episodes in a 12-month period. See a doctor before using for the prevention of recurrent BV. Use beyond 16 weeks is not recommended without medical supervision. VIRALEZE™: Not approved for use or supply in Australia. ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. This medical device is a regulated health product that bears, under this regulation, the CE marking in the EU. Do not use if you have a history of sensitivity to any ingredient in the formulation. Not for use in children under the age of 12 years. See a doctor If you are pregnant or breastfeeding. Always follow recommendations from health authorities, including vaccination and good hygiene practices, such as the use of masks, physical distancing, and regular handwashing to ensure the best possible protection against cold/respiratory viruses. 2 Starpharma is an innovative biopharmaceutical company and leader in dendrimer technology Innovative drug delivery platform, DEP® Proprietary nanoparticle platform; ability to create innovative therapies and enhance existing drugs; significant optionality; accelerates path to market; and manages investment risk. Deep portfolio of high-value assets Three promising internal clinical-stage assets are under development: improved, patented versions of widely used cancer medications. Strong pipeline of preclinical-stage assets, including radiotheranostics. Multiple products on market. DEP® Multiple global pharma partnerships DEP® partnerships with three of the world’s top 10 pharmaceutical companies: MSD, Genentech, and AstraZeneca. Starpharma generates returns via research fees, milestones and royalties. Funded by large pharma partners. DEP® platform offers the ability to partner widely without Starpharma funding programs. Strong financial position Strong balance sheet and runway with $35.6 million cash at 30 September 2023, excluding the $7.2M R&D tax incentive refund received in October 2023. SPL7013 Strong international institutional share register Institutions include Allianz, UIL/ICM, Allan Gray, M&G, and Fidelity. Starpharma Holdings Limited Annual General Meeting to Shareholders, 2023 3 2022-23 Operational highlights Expanded partnership with multinational pharmaceutical company, MSD, to explore the anticancer properties of DEP® Antibody-Drug Conjugates. Expanded partnership with leading biotech, Genentech, applying Starpharma’s DEP® platform to a number of novel therapeutic modalities. Reported positive Phase 2 results on DEP® cabazitaxel in patients with advanced prostate cancer, platinum-resistant ovarian cancer and gastrooesophageal cancers. Completed recruitment for the post-market clinical study of VIRALEZE™ nasal spray in patients with recently diagnosed COVID-19. Completed patient recruitment for all three in-house Phase 2 DEP® clinical trials: DEP® cabazitaxel, DEP® docetaxel and DEP® irinotecan. Positive DEP® irinotecan interim clinical results reported in advanced colorectal and platinumresistant/refractory ovarian cancer – presented at an AACR oncology conference in the US. Presented three DEP® posters at the International Conference on Molecular Targets and Cancer Therapeutics, hosted by the AACR, NCI, and EORTC in the US. Launched VIRALEZE™ antiviral nasal spray in Hong Kong and Macau through our commercial partner, Hengan, shortly after entering a distribution agreement. DEP® HER2-zirconium, Starpharma’s radiodiagnostic candidate, demonstrated imaging benefits in a HER2+ breast cancer model. These results were presented at the AACR-NCI-EORTC conference in the US. Newly developed internal DEP® Antibody-Drug Conjugate, HER2-targeted DEP® SN38 ADC, demonstrated significant anti-tumour activity in a HER2+ human ovarian cancer model. Negotiated a favourable commercial settlement agreement with Mundipharma in relation to VivaGel® BV, securing an A$6.6M cash payment and regaining all commercial rights, enabling Starpharma to pursue commercial interest from other partners. Achieved new registrations for VIRALEZE™ nasal spray in Indonesia and Malaysia, bringing the number of countries where VIRALEZE™ is registered to more than 35 globally. Starpharma Holdings Limited Annual General Meeting to Shareholders, 2023 4 Financial summary Strong balance sheet with revenues from product sales and partnerships • Strong cash position with $35.6M (30 September 2023). Cash at 30 September 2023 $35.6M o Excludes the $7.2M Research and Development Tax Incentive refund received in October 2023 and repayment of $4M low-interest R&D loan in October 2023. • Revenue for FY23 was $4.2M, which included VIRALEZE™ and VivaGel® product sales, royalties, licensing revenue from commercial partners and interest income. Key Financials FY23 $M FY22 $M FY21 $M • The FY23 loss continued to trend downwards. Revenue 4.2 4.9 2.2 • FY23 expenditure included R&D investment in DEP® programs (clinical and preclinical) and the post-market VIRALEZE™ study. Other Income 0.1 0.3 1.3 Loss for the period (15.6) (16.2) (19.7) Following the completion of these clinical programs, Starpharma expects reductions in operating costs in H2 FY24. Net operating cash outflows (13.5) (13.2) (14.8) • Starpharma Holdings Limited Annual General Meeting to Shareholders, 2023 5 Starpharma’s portfolio: multiple clinical-stage assets, partnerships and products in market DEP® pipeline Partnered DEP® programs Product Target indication Preclinical DEP® cabazitaxel Prostate and other cancers Phase 2 complete & results reported DEP® irinotecan Colorectal and other cancers Phase 2 recruitment complete DEP® docetaxel Pancreatic and other cancers Phase 2 recruitment complete DEP® HER-2 ADC Solid cancers DEP® HER-2 radiotherapeutic Solid cancers DEP® HER-2 radiodiagnostic Diagnostic Partnerships Various Phase 1 Phase 2 Two DEP® ADC Research Agreements with MSD (Merck & Co., Inc.) Two DEP® Research Agreements with Genentech DEP® anti-infective research partnership with Chase Sun Multiproduct DEP® Licence and Option Agreement with AstraZeneca Commercialised products VIRALEZE™ Antiviral Nasal Spray Starpharma Holdings Limited Annual General Meeting to Shareholders, 2023 VivaGel® BV VivaGel® Condom 6 Starpharma’s DEP® platform has broad applicability, creating multiple high-value commercial applications Chemotherapeutics Antibody-Drug Conjugates • Franchise extension • Generic differentiation • New chemical entities • Combinations including immuno-oncology • Flexible technology • Increased drug antibody ratio • Targeting group agnostic • Site selective payload attachment The DEP® platform can provide therapeutic and commercial value across a wide range of therapeutic areas and treatment modalities. Radiotheranostics Non-oncology • Radiotheranostic applications • Can use a variety of isotopes and targeting approaches • Applicable to antivirals and anti-infectives • Endocrinology Starpharma Holdings Limited Annual General Meeting to Shareholders, 2023 7 Starpharma's DEP® platform: highly versatile, enhancing the commercial and therapeutic value of a wide range of drugs Improved Safety/Reduced side effects Multiple DEP® therapeutic areas across partnered and internal programs DEP® technology: • • • Based on proprietary, branched polymers called dendrimers. Represents a platform with significant optionality – applicable to many different drugs. DEP® optimises drug properties and enables targeted therapy, creating differentiated products, managing a product’s lifecycle and creating new intellectual property. DEP® dendrimer-drug conjugate Control release kinetics of drug to reduce Cmax-related toxicities Improved Efficacy/Performance DEP® achieves drug targeting, improved PK and controlled release New IP/Extended Patent Life DEP® platform benefits Tumour Targeting DEP® delivers 40-70x more drug in tumour cf. the original drug Improved PK and Half-Life Tuning of drug release and plasma half-life to improve performance DEP® dendrimer antibodydrug (ADC) conjugate Rx DEP® dendrimer radiotheranostic DEP® creates new intellectual property and extends patent life Improved Solubility Highly water-soluble, removing the need for toxic excipients Broa